Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06047795
Other study ID # Rec/01657 Safa Marwa
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 11, 2023
Est. completion date July 2024

Study information

Verified date April 2024
Source Riphah International University
Contact Mehwish Waseem, MSPT-CPPT
Phone 0331-5309015
Email mehwish.waseem@riphah.edu.pk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To determine the effects of endurance training on functional capacity and QOL(Quality of life) in patients with post-TB (tuberculosis) lung disease. Post-tuberculosis lung disease is a major health concern nowadays. There is limited evidence in the literature regarding the rehabilitation of patients with cured tuberculosis which leads to post-TB complications.


Description:

Adults with post-TB respiratory symptoms experience skeletal muscle weakness due to inactivity, systemic inflammation, and poor nutrition, which is frequently made worse by poverty. Such patients experience a vicious cycle that includes decreased body weight, increasing morbidity, and higher mortality. People with Chronic Respiratory Diseases frequently avoid exercise, which causes them to lose motivation and decondition. This cycle of decline continues. In Pakistan, there is no concept of pulmonary rehabilitation for TB patients. The current study will attempt to fill this literature gap and also promote the concept of pulmonary rehabilitation for post-tuberculosis patients in Pakistan.


Recruitment information / eligibility

Status Recruiting
Enrollment 36
Est. completion date July 2024
Est. primary completion date June 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria: - TB (diagnosed) with Completed TB course - Dyspnea (with or without cough) - Age (18-50yrs). - After 3 months of AFB and gene expert (-) - Decreased PFT predicted values Exclusion Criteria: - Smoker, Diabetes, and cardiac patients - Physical disabled, pregnant (lactating women) - Sputum + testing for TB - Gene expert - CVD (unstable) - Not willing to participate

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Experimental
Cycling 2 days per week with Borg dyspnea 4-6 level for 15-20 minutes/ day with 5 minutes warm-up and cool-down. Strengthening exercises for upper limb muscles (pull-ups and biceps curls) and for lower limb muscles (sit-to-stand and step-up exercises) with 3 sets of 8-12 repetitions * 2 days per week. Pursed Lip breathing exercise 3 sets of 5-10 repetitions for 6 weeks
Control
Usual care: frontal chest radiographs, verbal advice to quit smoking, and reduce exposure to biomass smoke. Spirometry to screen for airway diseases. Antibiotic and systemic glucocorticoid therapy.

Locations

Country Name City State
Pakistan Green Star NGO Peshawar KPK

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Functional capacity Changes from baseline to 3 weeks and 6 weeks after the intervention, measured through 6 min walk test (6 MWT). It is a submaximal exercise test that can aid in assessing the functional capacity of patients with cardiopulmonary diseases, in this test we find out the maximum distance in meters that an individual covers in 6 min without any support. 3 weeks, 6 weeks
Primary Dyspnea Changes from baseline to 3 weeks and 6 weeks after the intervention, measured through the BORG dyspnea scale. it uses a scale from 0 to 10, where 0 represents no dyspnea and 10 represents maximal dyspnea. 3 weeks, 6 weeks
Primary Forced Expiratory Volume in 1 second (FEV1) Changes from the Baseline, the digital spirometer is used in the clinical setting to analyze Forced Expiratory Volume in 1 second FEV1 in Liters 3 weeks,6 weeks
Primary Forced vital Capacity (FVC) Changes From the Baseline, the digital spirometer is used in clinical setting to analyze Forced vital Capacity in Liters 3 weeks,6 weeks
Primary Peak Expiratory Flow (PEF) Changes from the Baseline, the digital spirometer is used in clinical setting to analyze peak expiratory flow PEF in Liter/second. 3 weeks,6 weeks
See also
  Status Clinical Trial Phase
Recruiting NCT05738681 - Efficacy of N-acetylcysteine to Prevent Anti-tuberculosis Drug-induced Liver Injury: A Randomized Controlled Trial Phase 2/Phase 3
Recruiting NCT05526885 - Tuberculosis Diagnostic Trial of CAD4TB Screening Alone Compared to CAD4TB Screening Combined With a CRP Triage Test, Both Followed by Confirmatory Xpert MTB/RIF Ultra in Communities of Lesotho and South Africa N/A
Completed NCT04369326 - Community Initiated Preventive Therapy for TB N/A
Recruiting NCT04568967 - TB-CAPT EXULTANT - HIV N/A
Completed NCT02337270 - Phase 1 Clinical Trial of the Safety and Immunogenicity of an Adenovirus-based TB Vaccine Administered by Aerosol Phase 1
Not yet recruiting NCT06253715 - Shortened Regimen for Drug-susceptible TB in Children Phase 3
Recruiting NCT04271397 - Immunological Biomarkers in Tuberculosis Management N/A
Withdrawn NCT03639038 - Tuberculosis Diagnosis by Flow Cytometry
Completed NCT03199313 - Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Sutezolid Phase 1
Recruiting NCT04975178 - Efficacy, Safety and Immunogenicity Evaluation of MTBVAC in Newborns in Sub-Saharan Africa Phase 3
Completed NCT04463680 - Rifampin and the Contraceptive Implant Phase 4
Completed NCT03973970 - Assessing the Ability of the T-SPOT®.TB Test (IQ)
Recruiting NCT04230395 - Alcohol Reduction Among People With TB and HIV in India N/A
Completed NCT04874948 - Absorption, Elimination and Safety of 14C-labeled Radioactive BTZ-043, a New Compound in TB Treatment Phase 1
Active, not recruiting NCT02906007 - Evaluating the Pharmacokinetics, Safety, and Tolerability of Bedaquiline in Infants, Children, and Adolescents With Multidrug-Resistant Tuberculosis, Living With or Without HIV Phase 1/Phase 2
Not yet recruiting NCT05917210 - Peer-led Implementation of TB-HIV Education and Adherence Counseling in Uganda N/A
Not yet recruiting NCT06017843 - Impact Evaluation of Use of MATCH AI Predictive Modelling for Identification of Hotspots for TB Active Case Finding N/A
Not yet recruiting NCT05845112 - Start Taking Action For TB Diagnosis
Active, not recruiting NCT02715271 - Study of TB Lesions Obtained in Therapeutical Surgery
Completed NCT02781909 - Potential Efficacy and Safety of Using Adjunctive Ibuprofen for XDR-TB Tuberculosis Phase 2